The UK government has released a position paper outlining its vision for Framework Programme 10 (FP10), a successor to Horizon Europe, the EU's flagship research collaboration program. 26 September 2024
The US Food and Drug Administration (FDA) on Friday approved Dupixent (dupilumab) as an add-on maintenance treatment of adults with inadequately controlled chronic obstructive pulmonary disease (COPD) and an eosinophilic phenotype. 28 September 2024
Shionogi said today that it has submitted a New Drug Application (NDA) in Japan for zuranolone, a treatment in development for major depressive disorder (MDD). 27 September 2024
China’s National Medical Products Administration (NMPA) has approved Dupixent (dupilumab) as an add-on maintenance treatment for adults with uncontrolled chronic obstructive pulmonary disease (COPD). 27 September 2024
A US Food and Drug Administration advisory committee meeting has recommended restricting the use of PD-1 inhibitors, in a move which could affect blockbuster products such as Bristol Myers Squibb's Opdivo (nivolumab) and Merck & Co's Keytruda (pembrolizumab). 27 September 2024
The US Food and Drug Administration yesterday approved pharma major Bristol Myers Squibb’s Cobenfy (xanomeline and trospium chloride) capsules for oral use for the treatment of schizophrenia in adults. 27 September 2024
The generics and biosimilars trade group, Medicines for Europe, has put out a strong message amid ongoing discussions on a European Union (EU) Critical Medicines Act. 26 September 2024
US biotech Emergent BioSolutions revealed it has secured approximately $400 million in orders in 2024 and 2025 associated with its vaccinia, smallpox and mpox product portfolio. 26 September 2024
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorization for Joenja (leniolisib), from Netherlands-based Pharming. 26 September 2024
The UK government has released a position paper outlining its vision for Framework Programme 10 (FP10), a successor to Horizon Europe, the EU's flagship research collaboration program. 26 September 2024
Shanghai-based Junshi Biosciences has announced that the European Commission has approved Loqtorzi (toripalimab) for two cancer indications. 26 September 2024
Amgen yesterday revealed that Tepezza (teprotumumab [genetical recombination]) has been approved for the treatment of active or high clinical activity score (CAS) thyroid eye disease (TED) in Japan. 25 September 2024
Eli Lilly's Kisunla has been approved in Japan for early symptomatic Alzheimer's disease, following its US approval in July 2024. Administered via IV infusion, it targets patients with mild cognitive impairment and dementia linked to amyloid pathology. Kisunla aims to slow cognitive and functional decline in AD patients 25 September 2024
Healthcare plan provider Centivo has raised $75 million in equity and debt financing to support its goal of offering affordable care to employees and their families. 25 September 2024
President Biden has said the USA will commit at least $500 million to support African countries in battling the ongoing mpox outbreak in Central and Eastern Africa. 25 September 2024
People affected Niemann-Pick disease, a rare and fatal genetic disorder, have waited a lifetime for an effective medicine. Now, in the space of a week, the US regulator has approved two. 25 September 2024
The Japanese Ministry of Health, Labor, and Welfare (MHLW) has approved Otsuka’s (TYO: 4578) Lupkynis (voclosporin) for the treatment of lupus nephritis (LN), an inflammation of the kidneys caused by systemic lupus erythematosus (SLE), an autoimmune disease 24 September 2024
CSL Vifor today announced that Japan’s Ministry of Health and Labor Welfare (MHLW) has granted its partner, Zeria Pharmaceutical marketing authorization approval for Veltassa (patiromer). 24 September 2024
The Pharmaceutical Research and Manufacturers of America (PhRMA) is continuing its legal challenge against the US government’s drug pricing reforms. 24 September 2024
As part of the US Obama Administration’s commitment to address the rising public health challenges caused by the national prescription opioids and heroin epidemic, Attorney General Loretta Lynch issued a memo this week announcing the department’s three-part prevention, enforcement and treatment strategy. 27 September 2016
In advance to the US-Ukraine Business Council (USUBC) working breakfast with President of Ukraine Petro Poroshenko to take place in New York with the attendance of several Ministers and members of the President top team along with Ambassador Valeriy Chaly, the Ukraine pharmaceutical industry trade group APRaD, being the USUBC member, received an opportunity to raise the main issues in health care/pharmaceutical fields in Ukraine. 27 September 2016
The US Food and Drug Administration (FDA) has accepted for priority review the Biologics License Application (BLA) for dupilumab, a treatment for adults with inadequately controlled moderate-to-severe atopic dermatitis (AD), a serious, chronic inflammatory skin disease. 26 September 2016
Pain Therapeutics has received a Complete Response Letter (CRL) from the US Food and Drug Administration on the resubmission of its New Drug Application for Remoxy ER (oxycodone capsules CII). 26 September 2016
The Irish Pharmaceutical Healthcare Association (IPHA) has agreed a new four-year framework agreement with the government for an economic and secure supply of medicines for patients, the trade group announced last week. 26 September 2016
Cash-rich since its $40.5 billion sale of its generics business to Teva Pharmaceutical Industries, Ireland -incorporated Allergan was on the takeover trial again last week, announcing two acquisitions, making its total buys in the year to date seven. 25 September 2016
A clear message was issued when Sir Andrew Dillon, chief executive of the National Institute for Health and Care Excellence (NICE). the medicines cost-effectiveness watchdog for England and Wales, addressed pharma leaders on Thursday. 24 September 2016
The US Food and Drug Administration has approved biotech major Amgen’s Amjevita (adalimumab-atto) across all eligible indications of the reference product, Humira (adalimumab). 24 September 2016
Novartis says that the US Food and Drug Administration has granted three simultaneous approvals for the expanded use of Ilaris (canakinumab) to treat three rare and distinct types of periodic fever syndromes. 24 September 2016
Janssen Biotech says it has submitted a Biologics License Application (BLA) to the US Food and Drug Administration seeking approval of sirukumab for the treatment of adult patients with moderately to severely active rheumatoid arthritis. 24 September 2016
A drug to treat a rare inherited bone disorder has been recommended for limited use by Britain’s pricing watchdog after being initially turned down for being too expensive last year. 23 September 2016
The National Institute for Health and Care Excellence (NICE) has recommended Epclusa (sofosbuvir-velpatasvir), from US biotech major Gilead Sciences, as a treatment option for all genotypes of hepatitis C in draft guidance published today. 23 September 2016
Teva Pharmaceutical Industries has announced that SD-809 (deutetrabenazine) showed statistically-significant results in the second Phase III registration trial studying the potential of SD-809 for the treatment of tardive dyskinesia (TD). 23 September 2016
Ireland is the latest country to put its name forward to host the European Medicines Agency (EMA), should it be relocated following the UK’s Brexit vote. 22 September 2016
Ireland-incorporated Allergan says that the European Commission has granted Marketing Authorization for Truberzi (eluxadoline) in Europe. 22 September 2016
US clinical-stage biotech firm bluebird bio revealed that the European Medicines Agency has granted access to its Priority Medicines (PRIME) scheme for LentiGlobin drug product in the treatment of patients with transfusion-dependent beta-thalassemia (TDT). 22 September 2016
Apricus Biosciences has announced the launch of Vitaros (alprostadil), Apricus’ novel on-demand topical cream for the treatment of erectile dysfunction (ED), in the Czech Republic and Slovakia by Italian drugmaker Recordati. 22 September 2016
Newron Pharmaceuticals and its partners Zambon and US WorldMeds announced today that Newron has re-submitted the New Drug Application (NDA) for Parkinson’s disease drug Xadago (safinamide) to the US Food and Drug Administration FDA. 22 September 2016